Knee OsteoarthritisLIFT-OANCT06462560
Live and Interactive Fitness Training Program (Vivo Knee OA)
A study testing Vivo Online Exercise Program and Medbridge Home program in people with Knee Osteoarthritis, run by Intermountain Health Care, Inc. at 1 site in United States.
Trial summary
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Vivo Online Exercise Program and Medbridge Home program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 334 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2024to Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55-85 years of age
- Diagnosis of Osteoarthritis within the prior 6 months
- Symptomatic OA defined as self-report:
- Pain in the knee(s) on most days of the month
- Difficulty with at least one of the following because of knee pain:
- walking ¼ of a mile
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- climbing stairs
- getting in and out of a car, bath, or bed
- rising from a chair
- or performing shopping, cleaning, or self-care activities
- Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
- Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
- Ambulatory and community-dwelling
- Sedentary or insufficiently active as measured by the PAVS
- Access to Wi-Fi in defined exercise space
- BMI of 20-34.9 kg/m2
- Document medication specific to OA and knee pain
- Willing and able to provide consent
Who cannot join
- Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
- Diagnosis of dementia
- Inability to complete ≥1 ADLs without assistance.
- Knee surgery in the past 6 months
- Severe osteoporosis T-score < -3.5
- No concurrent enrollment in physical therapy for knee pain
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- No concurrent enrollment in the Intermountain Arthrofit program
- Under the age of 55 or ≥85
- Asymptomatic OA
- Not having knee pain or having significant knee pain (WOMAC Pain score of ≤3 or ≥18)
- KL Grade 1 or 4
- BMI above 34.9 kg/m2 or ≤20 kg/m2
- Participation in formal strength training more than 30 minutes a week in the past 6 months.
- PAVS - Participating in 150 minutes per week of moderate intensity physical activity or 75 minutes of vigorous intensity activity, or an equivalent combination of moderate and vigorous intensity physical activity.
- Co-morbid disease that would threaten safety or impair ability to participate in a live and interactive strength training program
- Symptomatic or severe coronary artery disease; peripheral vascular disease
- Untreated hypertension
- Active cancer other than skin cancer
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Intermountain Health
Murray, Utah, 84107
Amelia Millward, 801-507-8095, amelia.millward@imail.org
Anthony Beutler, MD
About this study
Official title: Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.
- Conditions
- Knee Osteoarthritis
- Being tested
- Vivo Online Exercise Program, Medbridge Home program
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vivo Online Exercise ProgramOther
Virtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs
Medbridge Home programOther
At home exercise program accessed through exercise descriptions and short vidoes
| Study group | Role | What they receive |
|---|---|---|
| Vivo Online Exercise program | Experimental | Not described Receives: Other: Vivo Online Exercise Program |
| Medbridge Home Exercise Program | Active comparator | Not described Receives: Other: Medbridge Home program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint 1
Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.
Measured: 6 months post intervention
Secondary outcomes (8)
Secondary Endpoint 1
Changes from baseline in WOMAC score at 3 and 6 months.
Measured: 6 months post intervention
Secondary Endpoint 2
Changes from baseline in length of time (seconds) to do 1-leg balance stance at 3 and 6 months.
Measured: 6 months post intervention
Secondary Endpoint 3
Changes from baseline in seconds to complete the 8-foot up and go at 3 and 6 months.
Measured: 6 months post intervention
Secondary Endpoint 4
Changes from baseline in number of knee raises completed in 2-minute knee raise at 3 and 6 months
Measured: 6 months post intervention
Secondary Endpoint 5
Changes from baseline in number of arm-curls done in 30 seconds at 3 and 6 months
Measured: 6 months post intervention
Secondary Endpoint 6
Changes from baseline in PROMIS-Plus-Osteoarthritis of the Knee (OAK) score at 3 and 6 months
Measured: 6 months post intervention
Secondary Endpoint 7
Changes from baseline in exercise self-efficacy scale score at 3 and 6 months
Measured: 6 months post intervention
Secondary Endpoint 8
Changes from baseline in quality of life (SF-36 score) at 3 and 6 months
Measured: 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start28 Apr 2024
- Primary completionApr 2025 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 334 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Impactiv, Inc.
- Responsible party
- Sponsor
- Investigators
- Anthony Beutler, MD, Principal investigator, Intermountain Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462560
- Sponsor's protocol ID
- 1052693
- Acronym
- LIFT-OA
- Status last verified
- Jun 2024
- First submitted
- 12 Jun 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Physical Function and Quality of Life in Adults With Knee Osteoarthritis Utilizing an Online Live and Interactive Fitness Training Program (Vivo Knee OA)
- ClinicalTrials.gov ID
- NCT06462560
- Acronym / sponsor ID
- LIFT-OA / 1052693
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 334 participants (estimated)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- Impactiv, Inc.
- Study start
- 28 Apr 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 17 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Potential participants will be screened at clinic. Patients who meet eligibility criteria will be considered for study. After written informed consent is obtained, participants will complete baseline testing and participants who meet eligibility criteria will be randomized 1:1 to 2 treatment arms: Vivo Arm: Vivo twice a week for 6 months and Usual Care Arm: meet with ATC and given Medbridge home exercise program for 6 months. All participants will be followed for 12 months, and will be assessed at 3-,6-, and 12-months. All participants will complete functional assessments, OA patient reported outcomes measures, quality of life, exercise self-efficacy, and fall risk questionnaires, and health care utilization report at each testing visit. A subset of Vivo participants will be asked satisfaction questions at the 3 and 6 month time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vivo Online Exercise program | Experimental | Other: Vivo Online Exercise Program |
| Medbridge Home Exercise Program | Active comparator | Other: Medbridge Home program |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 55-85 years of age
- Diagnosis of Osteoarthritis within the prior 6 months
- Symptomatic OA defined as self-report:
- Radiographic KL grade II-III (using Kellgren and Lawrence criteria) of one or both knees
- Physically able to participate in strength training - able to do one chair stand unassisted in order to test change in 30-second chair stand
Key exclusion criteria (18 listed)
- Neurological conditions causing functional impairments (Parkinson's disease, MS, ALS)
- Diagnosis of dementia
- Inability to complete ≥1 ADLs without assistance.
- Knee surgery in the past 6 months
- Severe osteoporosis T-score < -3.5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vivo Online Exercise ProgramVirtual online exercise programs conducted by the Vivo team consisting of multiple time a week group live programs | Other | Vivo Online Exercise program |
| Medbridge Home programAt home exercise program accessed through exercise descriptions and short vidoes | Other | Medbridge Home Exercise Program |
Primary outcome
Primary Endpoint 1
Time frame: 6 months post intervention
Changes from baseline in number of chair stands done in 30-seconds at 3 and 6 months.
8 secondary outcomes
Secondary Endpoint 1
Time frame: 6 months post intervention
Secondary Endpoint 2
Time frame: 6 months post intervention
Secondary Endpoint 3
Time frame: 6 months post intervention
Secondary Endpoint 4
Time frame: 6 months post intervention
Secondary Endpoint 5
Time frame: 6 months post intervention
Secondary Endpoint 6
Time frame: 6 months post intervention
Secondary Endpoint 7
Time frame: 6 months post intervention
Secondary Endpoint 8
Time frame: 6 months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Beutler, MD principal investigator
Intermountain Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vivo Online Exercise Program and Medbridge Home program in people with Knee Osteoarthritis, run by Intermountain Health Care, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amelia Millward (801-507-8095, amelia.millward@imail.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Endpoint 1 (time frame: 6 months post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2024.